Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Kayam Churna: Take 3 5 grams orally at bedtime with water for 30 days.
Intervention2: Kayam Tablets: 1 to 2 tablets to be taken with water at bedtime daily for 30 days.
Intervention3: A
Sponsors
Sheth Brothers
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and Females between 30-60 years of age (both inclusive); 2. Participants agreeing with two or more of the following complaints for the last 3 months: a) Straining during at least 25% of defecations: b) Lumpy or hard stools at least 25% of defecations: c) Sensation of incomplete evacuation of at least 25% of defecations: d) Sensation of anorectal obstruction/blockage at least 25% of defecations: e) Manual maneuvers to facilitate at least 25% of defecations e.g., digital evacuation, and support of the pelvic floor: f) Fewer than three defecations per week; 3. Participants in whom loose stools are rarely present without the use of laxatives; 4. Participants having stool form between 1 to 3 on the Bristol Stool Form Scale; 5. Participants willing and able to provide signed informed consent form prior to any study related procedures; 6. Participants having hyperacidity; 7. Participants having gases and indigestion; 8. Participants having headaches induced by gases; 9. Comorbid participants on stable medication for the last three months, with no worsening of symptoms and/or need for hospitalization; can be enrolled in the study at per discretion of the investigator.
Exclusion criteria
Exclusion criteria: 1. Participants with diagnosed colonic inertia; 2. Participants who have recently undergone abdominal surgery; 3. Participants with a history of anorectal surgery; 4. Participants having functional gastrointestinal disorders other than functional constipation i.e. IBS, Belching disorders, etc; 5. Participants diagnosed with structural abnormalities, like anorectal: rectal prolapse, rectocele, rectal intussusceptions, anorectal stricture, solitary rectal ulcer syndrome, perineal descent, colonic or rectal mass or tumor with obstruction e.g. adenocarcinoma, colonic stricture: radiation, ischemia, diverticulosis intestinal obstruction; 6. Participants with serious uncontrolled & diagnosed systemic ailments like HIV, DM and Tuberculosis; 7. Participants with renal or liver dysfunction; 8. Participants with diagnosed neurological problems like, parkinson s disease, multiple sclerosis, sacral nerve damage for example prior pelvic surgery, tumor, and paraplegia; 9. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assessment of change in the frequency of bowel movements using a bowel diary will be done at screening, day 1, day 7, day 15, and day 30. 2.Assessment of change in stool form assessed by the Bristol Stool Form Scale using bowel diary will be done at screening, day 1, day 7, day 15, and day 30. 3.Assessment of change in other symptoms of functional constipation (e.g., straining on defecation, sensation of incomplete evacuation, sensation of anorectal blockage, manual maneuvers required, and average time spent for bowel evacuation) using a Visual Analog Scale (VAS) will be done at screening, day 1, day 7, day 15, and day 30. Timepoint: screening, day 1, day 7, day 15, and day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of change in abdominal bloating, gas, acidity, indigestion, and gas-induced headaches using the Modified Gastrointestinal Symptom Rating Scale (GSRS) will be done at screening, day 1, day 7, day 15, and day 30. 2.Global assessment for overall improvement by the investigator and patient using a 4-point scale will be done on day 15 and day 30. Timepoint: screening, day 1, day 7, day 15, and day 30. | — |
Countries
India
Contacts
Public ContactMr Gaurav Sheth and others
Sheth Brothers
Outcome results
None listed